MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510890

Device Problems Premature Activation (1484); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip premature deployment.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the duodenal papilla ostium during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, it was noted that the device could not expand.On a second attempt, the bolt connecting the four wires at the tip of the basket fell off.The procedure was completed with another trapezoid rx basket.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the duodenal papilla ostium during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, it was noted that the device could not expand.On a second attempt, the bolt connecting the four wires at the tip of the basket fell off.The procedure was completed with another trapezoid rx basket.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

H2: the content in section a1, section h6, and section h10 has been updated.Block h6: imdrf device code a150103 captures the reportable event of tip premature deployment block h10: the returned trapezoid rx was analyzed, and a visual inspection observed that the that the working length was bent, the side car rx was pushed back and stretched, and the tip of the basket was detached.A functional test was performed, and the basket was able to open despite the tip being detached.The reported event was not confirmed.The basket was returned with the tip detached; however, there is not enough evidence to confirm if the tip detached prematurely or as intended per the instructions for use (ifu).The ifu states, "in the event the biliary calculi cannot be crushed, the trapezoid rx wireguided retrieval basket has been designed for the basket tip to disengage minimizing the potential for the unreleasable stone entrapment".Additionally, it was found that the sidecar rx was pushed back and stretched, and the working length was kinked.It is most likely that the damage to the device was due to extra tension applied to the device during the procedure.Therefore, the most probable root cause is adverse event related to procedure.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17720592
• MDR Text Key: 323088550
• Report Number: 3005099803-2023-04811
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031483311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 53 KG